Subcutaneous insertion systems; devices and related methods

ABSTRACT

Embodiments relate to subcutaneous insertion systems comprising a surface device to be applied to a patient&#39;s skin and an insertion system for applying the surface device to the patient, wherein the applying can include subcutaneous insertion of a cannula or other element, and related devices and methods. The surface device comprises a surface for application to the skin of a patient and a subcutaneous element, such as a cannula, wire, filament or other device, extending from the skin&#39;s surface at an angle greater than 0 degrees and less than 90 degrees.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of application Ser. No. 16/097,449filed Oct. 29, 2018, which is a National Phase entry of PCT ApplicationNo. PCT/US2017/029353 filed Apr. 25, 2017, which claims the benefit ofU.S. Provisional Application No. 62/329,352 filed Apr. 29, 2016, each ofwhich is incorporated herein by reference.

TECHNICAL FIELD

Embodiments relate generally to medical devices, and more particularlyto subcutaneous insertion systems comprising a device to be applied to apatient and an insertion system for applying the device to the patient,wherein the applying can include subcutaneous insertion of a cannula orother element, and related devices and methods.

BACKGROUND

A variety of devices can be applied to a patient to provide a treatmentor monitor a patient condition. Some can do both. One example is aninfusion system used to deliver substances such as fluids andmedications into the subcutaneous layer of skin of a patient. Typically,a subcutaneous infusion system includes a site applied to the surface ofthe skin of a patient, the site having a cannula that is introduced intothe skin, as well as a tube extending from the site to, for example, aninfusion pump to deliver the substance. Another example is a patientmonitoring system used to check or monitor one or more conditions of apatient (e.g., blood levels, such as glucose or oxygen), which also caninclude a device applied to the skin of the patient and comprising acannula, filament, wire or other device introduced at least partiallysubcutaneously. For convenience, surface devices generally, whether forinfusion, monitoring or some other purpose, will generally be referredto herein as sites. In some embodiments, sites refer to sensors or“patch pumps”.

In current designs, it is typically necessary to introduce the cannulaor other device of the site into the skin of the patient whilemaintaining the site at a given orientation. The orientation of thecannula is also fixed, extending perpendicularly from a bottom surfaceof the site and therefore inserted straight into, or perpendicularly to,the surface of the skin. While this perpendicular orientation canrequire a shorter cannula and a shorter needle for insertion of thecannula while also being easy and convenient for user self-applicationusing an insertion aid device, perpendicular insertion can beinconvenient for some users, such as those with low body fat or who areactive and desire a more secure placement of the infusion device andcannula. Additionally, some users may wish to control the angle ofinsertion of the cannula, depending on location and anatomy, to increasecomfort and placement efficacy. Still others may find the perpendicularorientation difficult to administer when applying the site to somelocations on the body.

In addition, devices for assisting in insertion of the cannula of aninfusion device into the skin of the patient are known. For example,some devices utilize springs to automatically drive a needle into theskin of a patient to introduce the cannula of the site into thesubcutaneous layer. Because a needle is used to introduce the cannula ofthe infusion device into the subcutaneous layer of skin, there is a riskassociated with inadvertent exposure to the needle. Further, patientsmay react adversely to viewing the needle prior to insertion and may,for example, be reluctant to self-insert the needle into the skin. Priordevices may not adequately shroud the needle prior to and/or afterintroduction of the site.

Other issues of concern in the design and use of insertion devicesinclude ease of use by the patient and sterility. For example, somepatients may have difficulty loading an infusion device into aninsertion device.

It is therefore desirable to provide new designs for subcutaneousinserter devices and other devices used to assist in the introduction ofa device into the skin of a patient.

SUMMARY

Embodiments described or otherwise contemplated herein substantiallymeet the aforementioned needs; for example, an insertion devicecomprising a housing comprising a first end; a sleeve slidably arrangedat least partially in the housing; a cylinder hub at least partiallyarranged in the sleeve and the housing and comprising a shoulder portionand a body portion, the shoulder portion proximate to the first end ofthe housing; a needle hub slidably arranged in the cylinder hub andcomprising a needle; and a site comprising a patient side surface and asubcutaneous element, the subcutaneous element coupled to the site at anangle greater than 0 degrees and less than 90 degrees with respect tothe patient side surface, the site arranged within the housing such thatthe needle can pass through at least a portion of the site to enter thesubcutaneous element at the angle.

In an embodiment, a method comprises providing an insertion devicecomprising a housing comprising a first end, a sleeve slidably arrangedat least partially in the housing, a cylinder hub at least partiallyarranged in the sleeve and the housing and comprising a shoulder portionand a body portion, the shoulder portion proximate to the first end ofthe housing, and a needle hub slidably arranged in the cylinder hub andcomprising a needle; providing a site to be applied by the insertiondevice, the site comprising a patient side surface and a subcutaneouselement to be inserted by the insertion device, the subcutaneous elementcoupled to the site at an angle greater than 0 degrees and less than 90degrees with respect to the patient side surface; and configuring theinsertion device and the site to be coupled with one another such thatthe needle can pass through at least a portion of the site to enter thesubcutaneous element at the angle to insert the subcutaneous elementduring use.

In an embodiment, an insertion device comprises a housing comprising afirst end; a sleeve slidably arranged at least partially in the housing;a cylinder hub at least partially arranged in the sleeve and the housingand comprising a shoulder portion and a body portion, the shoulderportion proximate to the first end of the housing; and a needle hubslidably arranged in the cylinder hub and comprising a needle; whereinthe insertion device is configured to be coupled with a site to insert asubcutaneous element of the site subcutaneously, the subcutaneouselement coupled to the site at an angle greater than 0 degrees and lessthan 90 degrees with respect to a patient-contacting surface of thesite, the site coupled with the insertion device such that the needlecan pass through at least a portion of the site to enter thesubcutaneous element at the angle.

The above summary is not necessarily intended to describe eachillustrated embodiment or every implementation of the subject matterhereof. The figures and the detailed description that follow moreparticularly exemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in considerationof the following detailed description of various embodiments of thesubject matter in connection with the accompanying drawings, in which:

FIG. 1 is an exploded view of an insertion device according to anembodiment.

FIGS. 1A-H are perimeter shapes for sites, site pads, and sleeve padsaccording to various embodiments.

FIG. 2A is a top view of an insertion device in a “shipped” stateaccording to an embodiment.

FIG. 2B is a side cross-sectional view of the insertion device of FIG.2A.

FIG. 3A is a top perspective view of a cylinder hub of an insertiondevice according to an embodiment.

FIG. 3B is an end perspective view of the cylinder hub of FIG. 3A.

FIG. 4 is an end perspective view of a housing of an insertion deviceaccording to an embodiment.

FIG. 5A is a side perspective view of a needle hub of an insertiondevice according to an embodiment.

FIG. 5B is a side perspective view of a needle hub of an insertiondevice according to an embodiment.

FIG. 5C is a side exploded view of a needle hub of an insertion deviceaccording to an embodiment.

FIG. 6A is a top exploded view of a site according to an embodiment.

FIG. 6B is a side exploded view of a site according to an embodiment.

FIG. 6C is a back side view of a portion of a site according to anembodiment.

FIG. 6D is a top view of a site according to an embodiment.

FIG. 6E is a side cross-sectional view of the site of FIG. 6D.

FIG. 6F is a side view of a septum of a site accordingly to anembodiment.

FIG. 6G is a bottom view of a septum of a site accordingly to anembodiment.

FIG. 6H is a back side view of a septum of a site accordingly to anembodiment.

FIG. 6I is a front side view of a septum of a site accordingly to anembodiment.

FIG. 6J is a perspective view of a septum of a site accordingly to anembodiment.

FIG. 6K is a perspective view of a septum of a site accordingly to anembodiment.

FIG. 7 is an end perspective view of a sleeve of an insertion deviceaccording to an embodiment.

FIG. 8A is a top view of an insertion device in a “triggered” stateaccording to an embodiment.

FIG. 8B is a side cross-sectional view of the insertion device of FIG.8A.

FIG. 9A is a top view of an insertion device in a “retracted” stateaccording to an embodiment.

FIG. 9B is a side cross-sectional view of the insertion device of FIG.9A.

FIG. 10 is a cross-sectional side view of a site providing a sensor witha multi-surfaced housing according to an embodiment.

FIG. 11A is a top view of a site providing an elliptical patch pump orsensor with a multi-surfaced housing according to an embodiment.

FIG. 11B is a top view of a site providing a rectangular patch pump orsensor with a multi-surfaced housing according to an embodiment.

FIG. 12 is a schematic view of internal patch pump components accordingto an embodiment.

FIG. 13 is a side cross-sectional view of an insertion device in a“shipped” state using a patch pump, presented as an alternatecross-sectional view of FIG. 2A, according to an embodiment.

FIG. 14 is a side cross-sectional view of an insertion device in a“triggered” state using a patch pump, presented as an alternatecross-sectional view of FIG. 8A, according to an embodiment.

FIG. 15 is a side cross-sectional view of an insertion device in a“retracted” state using a patch pump, presented as an alternatecross-sectional view of FIG. 9A, according to an embodiment.

FIGS. 16A and 16B are side cross-sectional views of a patch pumpretention arrangement with the cylinder hub prior to and during needleretraction, respectfully, according to an embodiment.

FIG. 17 is a perspective view depicting retention fingers located at theend portion of the cylinder hub according to an embodiment.

While embodiments are amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit subject matter hereof to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of subject matter hereof in accordance with theappended claims.

DETAILED DESCRIPTION

Embodiments relate to subcutaneous insertion systems comprising a siteor other surface device to be applied to a patient and an insertionsystem for applying the site or other surface device to the patient,wherein the applying can include subcutaneous insertion of a cannula orother element, and related devices and methods. The site or othersurface device can comprise a device applied to the skin of the patientand comprising a cannula, filament, wire, sensor or other subcutaneouselement to be introduced at least partially subcutaneously into the skinof a patient. For convenience, sites and other surface devicesgenerally, whether for infusion, monitoring or some other purpose, willgenerally be referred to herein as sites. In some embodiments, sites mayrefer to sensors or “patch pumps”.

In an embodiment, a subcutaneous insertion system comprises a site andan insertion device for applying the site to the skin of a user. Thesite comprises a surface for application to the skin of a patient and asubcutaneous element, such as a cannula, filament, wire, sensor or othersubcutaneous element to be introduced at least partially subcutaneouslyinto the skin of a patient, extending from the surface at an anglegreater than 0 degrees and less than 90 degrees. The site can bepreloaded in the insertion device, which comprises a needle configuredto interact with the cannula or other subcutaneous element to insert thecannula or other subcutaneous element into the skin of the patient at anangle greater than 0 degrees and less than 90 degrees with respect tothe surface of the skin of the patient as the site is applied to thesurface of the skin of the patient by the insertion device. Theinsertion device is configured to retract and securely retain the needlein an inaccessible portion of the insertion device after insertion ofthe cannula or other subcutaneous element. In embodiments, thesubcutaneous insertion system can further comprise a set comprisingtubing and configured to be removably coupled to the site while on theskin of the patient in order to convey fluid from a source coupled tothe set to the patient via the tubing, site and cannula. In still otherembodiments, devices and elements other than tubing sets can bemechanically, electrically and/or communicatively coupled with the sitefollowing application to the skin of the patient. The site (or“payload”) can be circular, elliptical, rectangular, or modifications ofthose general shapes.

While the type of surface device and subcutaneous element can vary inembodiments, examples discussed herein generally relate to an infusionsite comprising a cannula. These examples are used without limitation oreffect on the scope of the claims, as various other types of devices andelements are contemplated and may or may not fall within the scope ofthe claims. Some of these other devices and elements include patientmonitoring systems and devices used to check or monitor one or moreconditions of a patient (e.g., blood levels such as glucose, carbondioxide, or oxygen) or body temperature, which also can include a deviceapplied to the skin and comprising a cannula, filament, wire, sensor orother device introduced at least partially subcutaneously. Still otherdevices can be used in embodiments for application in or on the skin ofa patient, including those with a different type of or without asubcutaneous element, with a plurality of subcutaneous elements, or witha subcutaneous element as well as surface elements (e.g., sensors orother devices configured to monitor a patient condition at the surfaceof the skin, independent of or in combination with a subcutaneouselement). In some embodiments, a site may comprise a “patch pump” orsimilar device which may include its own fluid reservoir, powermechanism, power supply, electronic circuitry and cannula insertionsystem.

Referring to FIG. 1, an exploded view of an embodiment of an insertiondevice 100 is depicted. As depicted, insertion device 100 comprises ahousing 110, a needle hub assembly 120, a cylinder hub 130, a biasingelement 140, a sleeve 150, a cap 160 and a lock pin 170.

Lock pin 170 secures cap 160 to housing 110 via an aperture 172 inhousing 110 and an aperture 174 in cap 160 and can also abut orotherwise interact with sleeve 150 to prevent sleeve 150 from movingwithin housing 110 and cap 160. This can prevent inadvertent activationof insertion device 100, such as if insertion device was inadvertentlydropped or jarred, while also providing a child safety feature. Lock pin170 can form part of or be coupled with a tear-away band 176 that can bepart of cap 160 or housing 172, such that removing tear-away band 176removes lock pin 170 and enables cap 160 to be decoupled from housing110 while also freeing sleeve 150 for movement. Cap 160 can comprise alabel 161 in embodiments, wherein the label identifies at least one of amanufacturer of insertion device 100, name of insertion device 100, aserial number of insertion device 100, a barcode or othercomputer-readable identifier, instructions or warnings with respect touse of insertion device 100, and the like. Cap 160 can include a raisedannular rib around its inner surface near the proximal end. This rib canbe continuous or discontinuous. In some embodiments, the choice of capdesign could be influenced by the sterilization method used on thedevice.

Insertion device 100 can be preloaded with or otherwise comprise a site180 including a central hub 181 extending upwardly from a top surface orside of site 180. In still other embodiments, site 180 is not pre-loadedwithin insertion device 100 and instead can be coupled with insertiondevice 100 just prior to application of site 180 to the skin of thepatient. Site 180 can be coupled with a site pad 182 and sleeve pad 184on a bottom surface or side opposing its top surface. In otherembodiments in which site 180 is differently configured and/or comprisesa different type of device, the configuration of site pad 182 and/orsleeve pad 184 can vary, or one or both could be omitted or replaced bya different element. Here and elsewhere in this document unlessotherwise specified, a “top” surface generally refers to an uppersurface as the drawing is oriented on the page, while a “bottom” surfacegenerally refers to the opposite, lower surface in the drawing, withoutlimitation with respect to how the device or element may be oriented inuse and operation or other situations. This convention is used for otherelements and features herein throughout as well, unless otherwisespecified.

Site pad 182 can couple or interface between site 180 and sleeve pad184, while sleeve pad 184 can be configured to removably secure site 180to sleeve 150 before application of site 180 to the skin of a patient.Sleeve pad 184 can comprise an adhesive layer, such as one comprisingTEGADERM or another similar adhesive suitable for application to humanskin or tissue, to removably couple site 180 to the skin of a patientafter activation of device 100, which separates sleeve pad 184 fromsleeve 150 as site 180 is applied to the skin of the patient. Theadhesive layer can be applied to or coupled with a bottom surface ofsleeve pad 184, or in another embodiment the adhesive layer can beapplied to or coupled with a different surface of or coupled to site180. In FIG. 1, a top surface of sleeve pad 184 is visible. Sleeve pad184 can also comprise a finger tab 186, which can be an additional layerof material or an area free of adhesive between sleeve pad 184 and theskin of the patient to enable the patient or a clinician to easily graspand remove site 180 from the skin of the patient or otherwise hold site180 via sleeve pad 184 with no or reduced interaction with the adhesivelayer.

One, some or all of site 180, site pad 182 and sleeve pad 184 can beprecoupled with one another within insertion device 100 (i.e., combinedor assembled together during manufacturing of insertion device 100), orin some embodiments they can be separate components combined uponactivation of device 100. For example, in one embodiment site 180 andsite pad 182 are precoupled with one another within insertion device 100during manufacturing, and subsequently the combination is coupled withsleeve pad 184, via an additional adhesive layer on a top surface ofsleeve pad 184 and/or on a bottom surface of site pad 182, only uponactivation of device 100 to apply site 180, along with site pad 182 andsleeve pad 184, to the skin of a patient. The perimeter 191 of each ofsite 180, site pad 182 and sleeve pad 184 can be a variety of shapes. Asshown in FIGS. 1A-H, the general perimeter 191 may be round, elliptical,oblong, rectangular, semi-rectangular, rounded rectangular, square,rounded square or some other shape in various embodiments. The site 180,site pad 182 and sleeve pad 184 may have a combination of such perimetershapes as well. In one embodiment, for example, site 180 and site pad182 have generally round perimeters while sleeve pad 184 has a generallyelliptical perimeter.

FIG. 2A depicts a top view of insertion device 100 in which cap 160 issecured to housing 110 by lock pin 170, and FIG. 2B depicts a sidesectional view of insertion device 100. A subcutaneous element, such asa cannula 188, extends from the bottom surface of site 180 at an anglegreater than 0 degrees and less than 90 degrees with respect to thatbottom surface. In embodiments, cannula 188 can be at an angle α (seeFIG. 6E) of between about 20 degrees and about 50 degrees, such asbetween about 25 degrees and about 35 degrees, for example about 30degrees. In other embodiments, cannula 188 can instead comprise a wire,filament, sensor, or other device or element configured to be insertedat least partially subcutaneously. An embodiment comprising a cannula isdiscussed herein by way of example only.

Site pad 182 and sleeve pad 184 each comprise an aperture 183 and 185(see FIG. 1), respectively, that enables cannula 188 to pass throughsite pad 182 and sleeve pad 184 when site 180 is applied to the skin ofa patient. Apertures 183 and 185 can be elliptical, which can be moreeasily compatible with the angle of cannula 188, or round or some othershape. Apertures 183 and 185 can have the same or different shapes,circumferences, relative placements on site pad 182 and sleeve pad 184,respectively, and other features and characteristics.

FIGS. 2A and 2B depict insertion device 100 in a post-manufacturingshipped state, and in an embodiment in which site 180 is preloaded ininsertion device, and cap 160 is secured to housing 110 by lock pin 170and includes tear-away band 176. Cap 160 comprises a cap post 162extending upwardly or away from an inner bottom surface of cap 160 at asimilar angle as cannula 188. Cap post 162 is hollow or otherwisecomprises an interior channel 164 to house cannula 188 in the shippedstate. The top or open end of cap post 162 is configured to support site180. In one embodiment, the open end of cap post 162 is stepped orgraduated such that a first portion 166 of cap post 162 supports site180 near one side or edge of site 180 and a second portion 168 of cappost 162 supports site 180 at or near its center, accommodating therelative angles between site 180 and cap post 162. As such, inembodiments second portion 168 and one or both of apertures 183 and 185are arranged to enable second portion 168 to pass therethrough andcontact the bottom surface of site 180 proximate, such as adjacent to orat least partially around, cannula 180. In embodiments, one or both offirst and second portions 166 and 168 can be configured to engage with acorresponding portion of site 180 to more securely support site 180within insertion device 100.

Site 180 is also supported or held in place within insertion device 100by an end portion 132 of cylinder hub 130 and trigger rib 152 of sleeve150. End portion 132 and trigger rib 152 can abut and/or support atleast a portion of a central hub 181 of site 180. In one embodiment, endportion 132 can further be configured to abut and/or support at least aportion of the top surface of site 180. Thus, like the end of cap post162 having first and second portions 166 and 168, end portion 132 ofcylinder hub 130 is also configured to support site 180 in anorientation in which the top and bottom surfaces of site 180 are neitherparallel nor perpendicular with the sidewalls of housing 110 and cap160. The bottom surface of site 180 is generally parallel to the topsurface of sleeve pad 184. In an embodiment shown in FIG. 2, site 180 isgenerally parallel with an end portion 169 of cap 160, wherein endportion 169 is not perpendicular with the sidewall of cap 160 and is notparallel with an end surface of housing 110. In general, the anglebetween end portion 169 and the sidewall of cap 160, as well as theangle between the top and bottom surfaces of site 180 and the sidewallsof cap 160 and housing 110, is similar to the angle at which cannula 188extends from the bottom surface of site 180 (i.e., an angle betweenabout 20 degrees and about 50 degrees, such as between about 25 degreesand about 35 degrees, for example about 30 degrees, in variousembodiments). In some embodiments, end portion 169 of cap 160 is notparallel to the bottom surface of site 180 and the angle between endportion of 169 of cap 160 and the sidewalls of housing 110 and cap 160may be a different angle, such as a right angle.

Referring also to FIGS. 3A and 3B, cylinder hub 130 is generally hollowand comprises a shoulder portion 131 and a body portion 133. Shoulderportion 131 can have a generally ovular or oblong cross-section, whilebody portion 133 also can be generally ovular, oblong or round. In oneembodiment, body portion 133 tapers slightly (i.e., the cross-sectiondiameter decreases) between shoulder portion 131 and a distal end ofcylinder hub 130. Shoulder portion 131 can comprise two tabs 134configured to engage with shoulders 112 (see FIG. 2B) of housing 110 tocouple cylinder hub 130 and housing 110 with at least a portion ofshoulder portion 131 abutting an inner surface of an end of housing 110.In one embodiment, and referring also to FIG. 4, an internal top surface114 of housing 110 can comprise a standing circular rib 116 configuredto interface with shoulder portion 131 to hold shoulder portion in placewithin housing 110. Housing 110 also comprises guide ribs 118 and sleevetabs 119.

Cylinder hub 130 further comprises apertures 136 (see FIG. 1) extendingfrom a first end of cylinder hub 130, through shoulder portion 131 viainternal guides 135 that form a channel in shoulder portion 131 toconnect with apertures 136 formed in body portion 133. Apertures 136 areconfigured to guide needle hub 120 within cylinder hub 130 and extendfrom shoulder portion 131 to about a midpoint of body portion 133.Apertures 136 are formed opposite each other, on opposing sides ofcylinder hub 130.

Body portion 133 comprises an aperture 137 configured to interact with acorresponding tab on needle hub 120. Body portion 133 also comprises aneedle guide 138 and previously mentioned end portion 132 that abutssite 180 as discussed above.

Referring to FIGS. 5A, 5B and 5C, needle hub 120 is configured to beslidably arranged within the hollow cylinder hub 130 (see FIG. 3A).Needle hub 120 comprises tabs 123 configured to slide within guides 135and apertures 136 of cylinder hub 130 (see FIG. 3B). Tabs 123 also caninteract with biasing element 140 (see FIG. 1), such as to compressbiasing element toward site 180 (as depicted in FIG. 2B). Needle hub 120further comprises needle retaining portion 124 and snap arm 126. Duringuse and operation, snap arm 126 interacts with both aperture 137 (seeFIG. 3A) of cylinder hub 130 (to initially retain needle hub 120proximate needle guide 138) and trigger rib 152 (see FIG. 2B) (todisengage snap arm 126 from aperture 137 to cause needle hub 120 andneedle 122 to be retracted within housing 110.

Referring to FIGS. 6A, 6B, 6C, 6D and 6E, site 180 is depicted, alongwith septum 190 and site cap 187. Septum 190 is configured to fit withincentral hub 181 and facilitate fluid communication between needle 122and cannula 188 in use. As can be seen in FIG. 6A, septum 190 isasymmetrical, having a slanted lower portion 192. An inner surface 189of central hub 181 is correspondingly slanted to accommodate septum 190.Site cap 187 fits on central hub 181 over septum 190 to secure septum190 therewithin. In use and operation of insertion device 100, needle122 enters site 180 via a side aperture 194 formed in central hub 181.Needle 122 passes through septum 190 within central hub 181 and exitssite 180 via needle aperture 196. As needle 122 passes through needleaperture 196, needle 122 enters cannula 188 (not shown in FIGS. 6A and6C) to insert cannula into the skin of a patient as site 180 is appliedto the skin of the patient. Needle 122 is then removed and retractedwithin insertion device 100, as will be discussed more below.

Referring to FIGS. 6F, 6G, 6H, 6I, 6J, and 6K, a septum 190 is depictedfrom various perspectives, for use in a site 180. Specifically, theviews shown are side, bottom, back side, front side, and multipleperspective views, respectively. As shown, septum 190 is generally madeup of a main body portion 193, an upper protrusion 195, and a slantedlower portion 192. Main body portion 193 is generally a verticallydisposed, cylindrical member which surrounds a cylindrical cavity 197.Extending vertically from main body portion 193 is a tapered, generallyconical, upper protrusion 195. Further, the main body portion 193 ismerged with a smaller diameter, generally cylindrical, slanted lowerportion 192 that extends across the bottom of the main body portion 193in an angled manner. Lower portion 192 has a planar, angled face 198 atits lower end. This angled face 198 contains an arch shaped aperture 199that provides a channel 177 that extends partially through the slantedlower portion 192 and merges with the cylindrical cavity 197 of the mainbody portion. Further, the slanted lower portion 192 further contains alower aperture 178 that provides access to the cylindrical cavity 197from the bottom of the septum 190. This lower aperture 178 furtherprovides a small recess from the bottom surface of the lower portion192.

Accordingly, the channel 177 formed within the septum 190 providesangled access for a cannula 188 that is inserted through a site 180 atvarious angles. The contours of the arch shaped aperture 199 and channel177 provide a versatile and functional passage and arrangement forcannula insertion. Accordingly, the when the cannula 188 is insertedthrough the aperture 196, wall 179, and channel 177 of lower portion192, a convenient seal is made possible by the septum 190.

Sleeve 150 is depicted in FIG. 7. Sleeve 150 comprises trigger rib 152.Sleeve 150 further comprises tabs 154 and guide channels 156, each ofwhich interacts with a corresponding portion of housing 110: tabs 154can interlock with sleeve tabs 119 (see FIG. 4) while guide channels 156can guide sleeve ribs 118 (see FIG. 4) on each side. The ends of guidechannels 156 can prevent further relative movement of housing 110 andsleeve during operation. Cylinder hub 130 is configured to be arrangedthrough central aperture 158, while a rib 159 in which central aperture158 is formed can be a stop or fixing point for biasing element 140,such that biasing element 140 is arranged between tabs 123 of needle hub120 and rib 159 in at least one operational state of insertion device100.

Biasing element 140 can comprise a spring, such as a coil spring, inembodiment. In other embodiments, some other type or form of biasingelement can be used. As discussed below, biasing element 140 iscompressed during application of site 180, and release of thecompression retracts needle 122 during use and operation of insertiondevice 100.

Referring to FIGS. 8A and 8B, insertion device 100 is depicted in a“triggered” state. To achieve the “triggered” state from the “shipped”state depicted in FIG. 2A, lock pin 170, tear-away band 176 and cap 160are removed. Insertion device 100 is placed on the skin of the patient,with the open bottom portion of sleeve 150 against and substantiallyparallel with the skin of the patient. Housing 110 is pushed toward theskin of the patient while sleeve 150 remains generally stationary withrespect to the skin of the patient. This advancement of housing 110causes site 180 and cannula 188, cylinder hub 130, needle hub 120 andneedle 122 to advance toward the skin of the patient until site pad 182is in contact with sleeve pad 184 that is already in contact with theskin of the patient and needle 120 has inserted cannula 188 into theskin of the patient. At the same time, biasing element 140 iscompressed. This is generally the state depicted in FIG. 8B, althoughsleeve pad 184 is not specifically depicted in this view.

In FIG. 8B, cannula 188 would be inserted into the skin of a patient ifso applied, and cannula 188 would enter the skin of the patient at anangle between 0 degrees and 90 degrees, as discussed above. Inembodiments, cannula 188 is about 6 mm to about 25 mm long, such asabout 13 mm long in one example embodiment and such as about 19 mm inanother example embodiment. The length of cannula 188 can vary in otherembodiments. Another advantage of the angled insertion of cannula 188can be an increased resistance to potential escape of the medicamentbeing infused, which might occur if a portion of the medicament were tofollow the exterior surface of cannula 188 to the surface of thepatient's skin. More particularly, if cannula 188 is inserted at anangle between 0 degrees and 90 degrees, such as about 30 degrees,instead of at 90 degrees as is conventional, cannula 188 can be longer,such as twice as long or more, yet penetrate to the same depth withinthe subcutaneous layer of the patient's skin.

Once housing 110, cylinder hub 130 and needle hub 120 advancesufficiently toward the patient's skin so that snap arm 126 (see FIG.5B) of needle hub 120 reaches trigger rib 152 (see FIG. 7), trigger rib152 causes snap arm 126 to disengage from aperture 137 (see FIG. 3A).Because biasing element 140 has been compressed during the movement ofhousing 110 and cylinder hub 130 toward the skin and relative to sleeve150, disengagement of snap arm 126 from aperture 137 by trigger rib 152causes needle hub 120 and needle 122 to be retracted upwardly away fromthe skin within cylinder hub 130 and housing 110 by the released forceof compressed biasing element 140, which engages with tabs 123 toretract needle hub 120. Insertion device is then in a “retracted” state.

Referring to FIGS. 9A and 9B, the “retracted” state of insertion device100 is depicted. Needle hub 120 is retracted within cylinder hub 130 andhousing 110 until needle 122 is substantially or fully within cylinderhub 130, such that it cannot be accessed or inadvertently “stick”someone after it has now been used to apply site 180 and insert cannula188. Biasing element 140 is generally relaxed, or at least lesscompressed than in either the “shipped” or “triggered” states.

Once site 180 has been applied to the skin of a patient, an infusion setcan be coupled to site 180 to enable an infusion pump or other fluidsource to deliver a fluid to the patient via site 180, in an embodimentin which site 180 is used for infusion. Examples of infusion sets aredisclosed in U.S. Pat. No. 9,192,717 to Cote et al., which isincorporated herein by reference in its entirety. In embodiments, theset can be coupled to site 180 in a plurality of different relativepositions (i.e., to change the side or angle from which infusion tubingof the set extends from site 180 to increase comfort and convenience tothe patient). In one embodiment, an infusion set can be coupled to site180 in at least different relative positions, such as with the needle ofthe set entering site 180 from one of four different sides spaced apartfrom another by about 90 degrees. In other embodiments, more or fewerrelative coupling relationships between site 180 and the set arepossible. Upon being coupled to site 180, a needle within the set passesthrough a side of central hub 180 and pierces septum 190, establishingfluid communication between the needle (and medical tubing coupledthereto via the rest of the set, such as from an infusion pump) andcannula 188.

In still other embodiments, devices other than infusion sets and tubingcan be coupled to site 180. In embodiments, this coupling can bemechanical, electrical, communicative or some combination of thesecoupling modalities. A set or other type of mechanical coupler can beused in embodiments, or a set can be omitted. To accommodate a varietyof different coupling types and configurations, the configuration ofsite 180 can vary in embodiments, as can the configuration, size andorientation of some or all of the components of insertion device 100.For example, in embodiments the configuration of portions of sleeve 150,cylinder hub 130 and/or needle hub 120, which can interact with site 180to abut and/or support site 180 within insertion device 100, can varyfrom those depicted as the configuration or type of payload (e.g., site180) of insertion device 100 varies. In various embodiments, however,insertion device 100 can be used to apply, including subcutaneously, atleast a portion of a site or other device at an angle between 0 degreesand 90 degrees to the skin of a patient. In some embodiments, theinsertion needle passageway through the site can always be used forattachment of a set buckle to the site after placement onto the skin ofa patient.

Additionally, site 180 can comprise additional elements or devices thatcommunicate, cooperate or support the subcutaneous element or thatotherwise provide a desired function. For example, in embodiments site180 can comprise a radio-frequency identification (RFID) tag, chip,circuit, memory, sensor, light-emitting diode (LED), user interface, orother device or feature. These various devices and features can collectdata, such as via the subcutaneous element or independently, and provideinformation to a user, clinician, other caregiver, computer or system.In still other embodiments, one or more components of site 180 cancommunicate with an external device, such as a meter, smartphone, smartwatch, tablet, handheld or bodyworn computer or device, laptop, network,computer terminal, data reader or virtually any other device. Thecommunications can be wired or wireless and can utilize one or morecommunication techniques including WIFI, BLUETOOTH, near- or far-fieldcommunications, or other techniques.

FIG. 10 provides a cross-sectional side view of one embodiment of a site280 depicted in a similar orientation to site 180 shown in FIG. 6E. Site280 provides a sensor 210, such as an analyte sensor, in amulti-surfaced, generally disc-shaped housing 212. The sensor 210 isshown with a proximal portion 214 as well as a sensing filament 216extending from the generally flat bottom surface 218 of the housing 212to distal portion 220 at an angle β. In some embodiments, angle β willbe about 30 degrees. The angled, sensing filament 216 has advantagesover a perpendicular filament as it can be twice as long and contactmuch more tissue in certain embodiments. In addition to one or moresensors 210, housing 212 may include a printed circuit board 222 andassociated electronics. In certain embodiments, sensors 210 of this typemay be used for monitoring analytes, such as glucose, in bodily fluids(blood, interstitial fluid, or others) where the sensing filament ispositioned below the skin surface and monitoring is in vivo.

Housing 212 is shown with a generally planar top housing surface 224 andan angled side housing surface 226 along at least one side. Theremaining side surface(s) 228 may be perpendicular to the top housingsurface 224 or may gradually slope down to the bottom surface 218, asdepicted in FIG. 10. The angled side surface 226 of the housing, makesit possible to appropriately fit the site 280 within the confines of anangled insertion device 100 (or 300) having a housing 110 and sleeve 150disposed similar to the arrangement depicted in FIG. 2B. In someembodiments the angled side surface is oriented at an angle generallyconsistent with the sensing filament 216 or other subcutaneous element.Further, the partially angled housing surface configuration can permitmounting and delivery of site components which have a desired crosssection, such as a circular cross-section. This cross-section can matcha desired cross section of a sleeve 150 of an insertion device 100, forexample. Top housing surface 224 contains a clearance aperture 230. Thisaperture 230 provides an angled hole for passage of an introducer needle122. The housing and sensor arrangement of the site 280 accordinglypermit a sensor that may be introduced and secured by angledintroduction of a needle 122 and sensing filament 216.

Another type of site that may be provided by an insertion device is a“patch pump”. For purposes of this application, “patch pumps” refer tosmall infusion pumps that can be adhered directly to the skin for wear.Such patch pumps can be used to infuse a variety of fluids ormedicaments. Patch pumps include insulin pumps which can provide insulinto diabetic users; however, their usefulness can extend beyond insulindelivery to the delivery of other medicaments. In some embodiments,patch pumps involve no tubing, readily adhere to the body, are small,lightweight, completely or partially disposable, and are capable ofbeing worn and manipulated discreetly under clothing. Some patch pumpsare controlled wirelessly by a separate controller.

FIGS. 11A-17 and the corresponding description generally depict patchpumps (i.e. sites 380) and corresponding features of an insertion device300. This insertion device 300 should be understood to generally operatein a corresponding manner to insertion device 100 with some variationsnecessary for the accommodation of the particular dimensions andparameters of the site 380 rather than a site 180. These differencesinclude a different retention arrangement of the site 380 that isdiscussed in further detail in connection with FIGS. 13-17. While thedetails of a patch pump site 380 are more specifically addressed below,a sensor site 280 of similar housing shapes and/or arrangements shouldbe understood to be fully disclosed by this description as well.

FIG. 11A is a top view of a site or elliptical patch with amulti-surfaced housing 312 according to an embodiment. The ellipticalpatch pump 380 includes a generally planar top housing surface 324 andan angled side housing surface 326. The patch pump 380 is shaped andsized such that it can be applied by an angled insertion device 300 witha circular cross section across its sleeve 150. Patch pumps 380 of avariety of shapes and sizes are possible, but must be appropriatelyshaped to fit within the cross section of the desired angled insertiondevice 300.

FIG. 11B is a top view of a site constituting a rectangular patch pump380 a with a multi-surfaced housing 312 a according to an embodiment.The rectangular patch pump 380 a includes a generally planar top housingsurface 324 a and an angled side housing surface 326 a. The patch pump380 a is shaped and sized such that it can be applied by an angledinsertion device 100 with a square cross section across its sleeve 150.

Although not depicted in FIGS. 11A and 11B, a patch pump 380 cangenerally contain an adhesive pad across its bottom surface whendeployed on a user in certain embodiments, which will extend beyond andaround the perimeter of the housing 312. Adhesive pads of this type canbe adapted for use over periods of long term wear in some embodiments.

FIG. 12 sets forth a schematic diagram of the internal components of apatch pump 380 inside housing 312. The housing 312 can be watertight orotherwise impermeably sealed in various embodiments. The patch pump 380generally contains a fluid reservoir 332, a drive mechanism 334, a powersupply 336, electronic circuitry 338 and an angled access cannulainsertion system 340. The components are generally coupled with oneanother, but do not require tubes or similar components subject toocclusion or similar malfunction in certain embodiments. In general,fluid reservoir 332 can hold a limited supply of insulin or othermedicament. In certain embodiments, the fluid reservoir 332 may bereplaceable. However, the fluid reservoir 332, or entire patch pump 380,may be disposable once the fluid reservoir 332 is used. Drive mechanism334 can comprise a variety of types of pumping mechanisms sized for thepatch pump and will generally be controlled by electric circuitry 338.The electronic circuitry 338 can program fluid delivery andcommunications. Electronic circuitry 338 can include a controller or canbe controlled wirelessly by a controller located outside the pumphousing 312. The power supply 336 can comprise one or more batteries invarious embodiments. The angled access cannula insertion system 340provides an access passageway and features which enable safe applicationof the patch pump 380 to a user. This cannula insertion system 340 caninclude all insertion related features and passages of the patch pump380 and can be better understood in the subsequent figures anddiscussion of the application.

Referring to FIG. 13, a side cross-sectional view of an insertion device300 in a post-manufacturing “shipped” state, for use applying apreloaded patch pump 380. This view is presented as an alternatecross-sectional view of FIG. 2A. A subcutaneous element, such as acannula 388, extends from the bottom surface of patch pump 380 at anangle greater than 0 degrees and less than 90 degrees with respect tothat bottom surface. In embodiments, cannula 388 can be at an angle β(see FIG. 16A) of between about 20 degrees and about 50 degrees, such asbetween about 25 degrees and about 35 degrees, for example about 30degrees.

Site pad 182 and sleeve pad 184 each comprise an aperture that enablescannula 388 to pass through site pad 182 and sleeve pad 184 when patchpump 380 is applied to the skin of a patient. Patch pump 380 ispreloaded in insertion device 300, and cap 160 is secured to housing 110by lock pin 170 and includes tear-away band 176. In some embodiments, asshown in FIG. 13, the top or open end of cap post 162 is configured tosupport patch pump 380 with stepped or graduated features. In someembodiments, no cap post 162 will be present for support of a patch pump380. In both embodiments, with or without a cap post 162, support forthe patch pump 380 can also rely on an arrangement of retention fingers350 that can extended from the end portion 132 of cylinder hub 130 intothe attachment aperture 352 of the patch pump 380.

End portion 132 of cylinder hub 130 is also configured to support patchpump 380 in an orientation in which the top surface 354 and bottomsurface 356 of patch pump 380 are neither parallel nor perpendicularwith the sidewalls of housing 110 and cap 160. In an embodiment shown inFIG. 13, the bottom surface 356 of patch pump 380 is generally parallelwith an end portion 169 of cap 160, wherein end portion 169 is notperpendicular with the sidewall of cap 160 and is not parallel with anend surface of housing 110. In general, the angle between end portion169 and the sidewall of cap 160, as well as the angle between the topand bottom surfaces of patch pump 380 and the sidewalls of cap 160 andhousing 110, is similar to the angle at which cannula 388 extends fromthe bottom surface of patch pump 380 (i.e., an angle between about 20degrees and about 50 degrees, such as between about 25 degrees and about35 degrees, for example about 30 degrees, in various embodiments). Insome embodiments, end portion 169 of cap 160 is not parallel to thebottom surface of patch pump 380 and the angle between end portion 169of cap and the sidewalls of housing 119 and cap 160 may be a differentangle, such as a right angle.

FIG. 14 is a side cross-sectional view of an insertion device depictedin a “triggered” state for applying a patch pump 380. This is presentedas an alternate cross-sectional view of FIG. 8A. In this state, asshown, lock pin 170, tear-away band 176 and cap 160 have been removedand insertion device 300 has been placed on the skin of the patient.Specifically, the open bottom portion of sleeve 150 has been placedagainst and parallel with the skin of the patient. Housing 110 has beenpushed toward the skin while sleeve 150 remains generally stationarywith respect to the skin. Patch pump 380, cannula 388, cylinder hub 130,needle hub 120 and needle 122 have been advanced toward the skin untilpatch pump 380 is in contact with the skin and needle 120 has insertedcannula 388 into the skin. This arrangement would insert a cannula 388into the skin of the patient at an angle between 0 degrees and 90degrees.

Once housing 110, cylinder hub 130 and needle hub 120 advancesufficiently toward the skin that snap arm 126 of needle hub 120 reachestrigger rib 152, trigger rib 152 causes snap arm 126 to disengage fromaperture 137. Because biasing element 140 has been compressed during themovement of housing 110 and cylinder hub 130 toward the skin andrelative to sleeve 150, disengagement of snap arm 126 from aperture 137by trigger rib 152 causes needle hub 120 and needle 122 to be retractedupwardly away from the skin within cylinder hub 130 and housing 110 bythe released force of compressed biasing element 140, which engages withtabs 123 (See FIG. 5A) to retract needle hub 120. Insertion device 300is then in a “retracted” state.

FIG. 15 is a side cross-sectional view of an insertion device 300 in a“retracted” state using a patch pump 380. This view is presented as analternate cross-sectional view of FIG. 9A. Needle hub 120 is retractedwithin cylinder hub 130 and housing 110 until needle 122 issubstantially or fully within cylinder hub 130, such that it cannot beaccessed or inadvertently “stick” someone after it has now been used toapply patch pump 380 and insert cannula 388. Biasing element 140 isgenerally relaxed, or at least less compressed than in either the“shipped” or “triggered” states.

Once patch pump 380 has been applied to the skin of a patient, theneedle 122 is retracted, leaving the cannula 388 of the patch pump 380inserted in the desired patient location. As the needle 122 is retractedfrom the passageway in the pump, retention fingers 350 of the cylinderhub 130 are permitted to disengage from the patch pump 380. Thisdisengagement results in the patch pump 380 being separated from therest of the insertion device 300. Accordingly, retraction of the needleallows the retention fingers 350 to move inward during removal.Operation of the retention fingers 350 is described in greater detail inFIGS. 16A-17 and the related disclosure.

FIGS. 16A and 16B are side cross-sectional views of a patch pumpretention arrangement with the cylinder hub 130 prior to and duringneedle retraction, respectfully. In FIG. 16A, patch pump 380 having ahousing 312 with a top housing surface 354, angled side surface 355, andbottom surface 356 is shown. The top housing surface 354 contains anattachment aperture 352 which provides an angled passageway 358 throughthe housing 312 at an angle that is generally parallel to that of theangled side surface 355. Accordingly, in some embodiments the angledside surface 355 is oriented at an angle generally consistent with thecannula 388 or other subcutaneous element. The angled passageway 358provides space for a needle 122 to pass through the housing 312 and alocation for securing the patch pump 380 to the cylinder hub 130 of theinsertion mechanism 300 until the needle 122 is retracted.

The angled passageway 358 begins to extend inward from the attachmentaperture 352 in an angled manner with a smooth surface diameter.Partially into the angled passageway 358 an annular constriction 360protrudes inward from the perimeter before the angled passageway 358again widens to a section 362 of smooth diameter that houses aself-sealing septum 364. The angled passageway 358 is reduced to afinal, narrow diameter passage 366 leading to the bottom housing surface356, out of which cannula 388 extends in an angled manner from thehousing 312.

In FIG. 16A, features of the cylinder hub 130, consisting of retentionfingers 350 (also interchangeably and more specifically identifiedindividually as 350 a, 350 b . . . etc. in the figures and description),extend into the angled passageway 358. In the embodiment shown, only afirst retention finger 350 a and a second retention finger 350 b arepresent, surrounded by a central passageway 368. In other embodiments, agreater number of retention fingers 350 can be present which areradially surrounded by the central passageway 368 in a spaced-apartmanner. The retention fingers 350 have a generally smooth inner surface370 partially surrounding the central passageway 368 which is inadjacent contact with the surface of the needle 122 extendingtherethrough. The outer surface portion 372 of the retention fingers 350is generally smooth for a distance as it extends from the cylinder hub130 into the contoured angled passageway 358 of the housing 312. Arecessed section 374 is present partway along the outer surface 372 aswell as an outwardly extending tab 376 extends toward the passagewaywall at or near the distal end of the retention finger 350. In theinitial retained position, the retention fingers 350 are engaged withinthe angled passageway 358 such that the outwardly extending tab 376 islocated in the wider section 362 of the angled passageway 358 beyond theannular constriction 360. In this position, the annular constriction 360projects inwardly toward recessed section 374 of the retention finger350. The retention fingers 350 are generally held in place when needle122 extends through the central passageway 368 as the needle 122interferes with the ability of the retention fingers 350 to flexinwardly so that the annular constriction 360 and outwardly extendingtabs 376 interfere with movement past each other.

FIG. 16B shows the release of the patch pump 380 upon retraction of theneedle 122. Once the needle 122 has carried out angled insertion into apatient to properly place cannula 388 into the desired location, theneedle 122 is retracted through the cannula 388, self-sealing septum364, and through the central passageway 368 between the retentionfingers 350. As the needle 122 is withdrawn from the central passageway368, the retention fingers 350 are free to flex inwardly into the spaceof the central passageway 368 so that the annular constriction 360 nolonger interferes with movement of the tabs 376. Accordingly, the patchpump 380 is freely released from the retention fingers 350 and remainsdeployed on a patient. This release enables the remaining features ofthe insertion mechanism 300 to be separated from the patch pump 380.Medicament reaches the top end of the cannula 388 through a cavity, notshown, below self-sealing septum 364 that is in fluid communication withfluid reservoir 332.

FIG. 17 is a perspective view depicting one embodiment of a pair ofretention fingers 350 a and 350 b that could be used as part of the endportion 132 of the cylinder hub 130. Each retention finger 350 a and 350b has a smooth inner surface 370 and a projecting tab 376 extendingoutwardly at the distal end 378. The tab portion consists of a firstprojecting flat surface 382, a flat end surface 384, and an angled flatsurface 386 extending between the surfaces 382 and 384. Various shapesand sizes may be used for tabs to provide secure engagement within thecontoured passageway. In general, however, rigid outward extension ofthe tabs 376 is held in place and is made possible based on interferenceof a central needle 122, when present, with the inside smooth surfaces370 of the retention fingers 350 a and 350 b.

It should also be appreciated that the exemplary embodiment or exemplaryembodiments are only examples, and are not intended to limit the scope,applicability, or configuration of the invention in any way. Rather, theforegoing detailed description will provide those skilled in the artwith an enabling disclosure for implementing the exemplary embodiment orexemplary embodiments. It should be understood that various changes canbe made in the function and arrangement of elements without departingfrom the scope of the subject matter hereof as set forth in the appendedclaims and the legal equivalents thereof.

The embodiments above are intended to be illustrative and not limiting.Additional embodiments are within the claims. Although subject matterhereof has been described with reference to particular embodiments,workers skilled in the art will recognize that changes may be made inform and detail without departing from the spirit and scope of thesubject matter.

Various modifications to subject matter hereof may be apparent to one ofskill in the art upon reading this disclosure. For example, persons ofordinary skill in the relevant art will recognize that the variousfeatures described for the different embodiments of the invention can besuitably combined, un-combined, and re-combined with other features,alone, or in different combinations, within the spirit of the subjectmatter. Likewise, the various features described above should all beregarded as example embodiments, rather than limitations to the scope orspirit of the subject matter. Therefore, the above is not contemplatedto limit the scope of the subject matter.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of 35 U.S.C. § 112(f) are not to be invoked unless thespecific terms “means for” or “step for” are recited in a claim.

1-20. (canceled)
 21. An insertion site, comprising: a patient-sidesurface; a central hub having a side aperture formed therein; asubcutaneous element coupled to the site at an acute angle; and a septumhaving a longitudinal axis that is coaxial with a longitudinal septumaxis of the central hub extending substantially orthogonally from thepatient side surface, wherein the side aperture of the central hubconfigured to enable an insertion needle to pass through the septum atan oblique angle relative to the longitudinal septum axis, to enter thesubcutaneous element at the oblique angle.
 22. The insertion site ofclaim 21, wherein the acute angle is between about 20 degrees and about50 degrees.
 23. The insertion site of claim 21, when the patient-sidesurface comprises an adhesive layer configured to removably couple theinsertion site to tissue.
 24. The insertion site of claim 21, wherein aperimeter of the patient side surface is one of round, elliptical,oblong, rectangular, semi-rectangular, rounded rectangular, square,rounded square, or a combination thereof.
 25. The insertion site ofclaim 21, further comprising a finger tab configured to enable a user toeasily grasp and remove the insertion site from the tissue.
 26. Theinsertion site of claim 21, wherein the septum and the subcutaneouselement are in fluid communication with one another.
 27. The insertionsite of claim 21, further comprising a site cap configured to secure theseptum within the central hub.
 28. The insertion site of claim 21,wherein the subcutaneous element comprises a cannula.
 29. The insertionsite of claim 21, wherein the central hub of the insertion site isconfigured to selectively coupled to an infusion set.
 30. The insertionsite of claim 21, wherein the subcutaneous element comprises an analytesensor.
 31. The insertion site of claim 21, wherein the insertion siteis configured to wirelessly communicate with an external device.
 32. Theinsertion site of claim 21, wherein the site comprises a patch pump. 33.A method of deploying a subcutaneous element at an acute angle relativeto a surface of a skin of a patient to improve a likelihood of landingthe subcutaneous element in a subcutaneous layer of the patient, themethod comprising: providing a insertion site to be applied to a skin ofa patient, the site comprising a patient-side surface, a central hubhaving a side aperture formed therein, a subcutaneous element coupled tothe site at an acute angle, and a septum having a longitudinal axis thatis coaxial with a longitudinal septum axis of the central hub extendingsubstantially orthogonally from the patient side surface, passing aninsertion needle through the septum at an oblique angle relative to thelongitudinal septum axis, to enter the subcutaneous element at theoblique angle.
 34. The method of claim 33, when the patient-side surfacecomprises an adhesive layer configured to removably couple the insertionsite to tissue.
 35. The method of claim 33, wherein a perimeter of thepatient side surface is one of round, elliptical, oblong, rectangular,semi-rectangular, rounded rectangular, square, rounded square, or acombination thereof.
 36. The method of claim 33, wherein thesubcutaneous element comprises a cannula.
 37. The method of claim 33,wherein the central hub of the insertion site is configured toselectively coupled to an infusion set.
 38. The method of claim 33,wherein the subcutaneous element comprises an analyte sensor.
 39. Themethod of claim 33, wherein the insertion site is configured towirelessly communicate with an external device.
 40. The method of claim33, wherein the site comprises a patch pump.